Xx pharmacy in xx county renewed its New Drug Business License on 20xx 65438+ 10/day. Pharmacy business address: Monkey Shi Cun, Xiajiabao Town, Qingyuan Manchu Autonomous County Business mode: retail pharmacy. Our business scope includes Chinese patent medicines, chemical preparations, antibiotic preparations and biochemical drugs.
The pharmacy in our hospital has 2 employees, including pharmacists 1 person, provincial bureau training 1 person, and 5 groups of Chinese and western medicine cabinets, which are classified and placed according to GSP requirements. There is no special drug management, but air conditioners, refrigerators, thermometers, fire extinguishers, computers and other acceptance and maintenance equipment and facilities, as well as office equipment have been purchased.
According to the GSP implementation rules, the pharmacy in our hospital carried out self-examination, rectification and improvement, which made the drug quality management in our pharmacy fully implemented, thus improving the quality management level of the pharmacy. Now, explain the implementation and self-examination.
(1) Management responsibilities
In order to carry out and implement GSP certification in an all-round way, the pharmacy first revised and improved the quality management system and post quality responsibilities in combination with the actual situation of the enterprise and GSP requirements, and learned and conveyed them to all the staff of the pharmacy in time.
(2) Personnel and training
At present, the pharmacy has two employees, and the person in charge of the enterprise is a secondary school graduate with the title of pharmacist. Familiar with laws and regulations related to drugs. Zhang He, the person in charge of quality, has a high school education and is trained by the provincial bureau. All of them have passed the training and examination by the drug supervision and administration department and are certified to work. All the above personnel hold health certificates and establish health records.
Since the establishment of the pharmacy, the annual training plan will be made at the beginning of each year and implemented as planned. Over the past year, pharmacies have organized all kinds of trainings for four times, including 1 training on legal system of drug management, 1 training on quality management system of pharmacies, and 1 training on professional knowledge of drugs, with the participation of drug regulatory authorities.
Organize GSP training 1 time, and the quality management personnel of our store participate in the continuing education organized by the provincial US Food and Drug Administration every year.
(3) Facilities and equipment
Our business premises are 36 square meters, and the environment is clean and tidy. Business premises and office life are separated. The doors and windows are well-structured, and the shelves and counters are complete. Equipped with various facilities and equipment suitable for drug storage and display, mainly including 1 freezer, 5 drug racks, 1 air conditioner, 1 thermometer, 2 mousetraps, dark curtains, etc.
(4) Procurement and acceptance
Our store purchases drugs in strict accordance with the provisions and procedures of the drug procurement system. Strictly review the legitimacy of suppliers, purchasing drugs and suppliers' sales personnel, and sign quality assurance agreements with suppliers every year to clarify the quality terms. All drugs purchased have legal bills, and purchase records have been established, and the tickets, accounts and goods are consistent.
For the purchased drugs, the acceptance personnel shall accept them batch by batch according to the original documents, and establish acceptance records. At the time of acceptance, the appearance, internal and external packaging, labels, instructions, labels and other materials of the drug should be inspected in detail as required, and the first variety should have the inspection report of the drug batch number.
(5) Display and storage
When displaying drugs, drugs and non-drugs should be separated, prescription drugs and over-the-counter drugs should be separated, oral drugs and external drugs should be separated, and scattered drugs and easily-smelled drugs should be displayed in counters. Goods should be placed neatly and beautifully, category labels should be placed accurately, and the handwriting should be clear. Check and record the displayed drugs on time, and deal with quality problems in time.
Our store checks the drugs in stock on time and establishes maintenance records. For drugs with a validity period of 6 months, we fill in the Recent Drug Promotion Form every month. Monitor and record the temperature and humidity of the pharmacy every morning and afternoon, and take timely control measures when it is found to be beyond the specified range. Maintain regular inspection and maintenance of instruments and equipment, and establish equipment files.
Drug display is divided into qualified area, pending inspection area, return area and unqualified area. And implement color code management as required.
(6) Sales and service
In sales, our store abides by relevant laws, regulations and systems, and the clerk can correctly introduce the usage and precautions of drugs. There is an information desk in the business place, the service convention is clearly stated in the store, the supervision telephone number is announced, and the customer suggestion book is set up. Be able to take customers' criticisms or complaints seriously, handle them in time and make records. There are no advertisements for illegal drugs in the shop.
Our store conducted a comprehensive self-examination in accordance with GSP terms on 20xx 165438+ 10, and all the preparations for certification have been basically put in place. Due to the higher requirements of the new GSP, our pharmacy needs to be further improved. We are now applying for an extension of certification and look forward to the approval of the competent leadership of the Food and Drug Administration.
Model Report on Drug Safety Self-inspection II
In order to actively respond to the spirit of Lvliang Food and Drug Administration's Document [20xx] No.85 "Notice on Further Strengthening the Safety Production Management of Pharmaceutical Production Enterprises" and do a good job in drug safety production, our company organized and carried out a major investigation of hidden dangers in safety production. The specific implementation process is as follows:
I. Organizational leadership
The unit has set up a leading group for self-examination of hidden dangers in drug safety production. The leading group for the investigation and rectification of hidden dangers in production safety shall conduct unified leadership, unified arrangement and unified deployment for the implementation of this plan. Study and solve the outstanding problems existing in the investigation and rectification of hidden dangers in production safety, and coordinate the rectification work.
Team leader:
Deputy team leader:
Members:
Second, the scope and focus
Scope of inspection: conduct a comprehensive investigation and rectification of all kinds of hazards in all aspects of drug production, management, storage, use, transportation and waste disposal.
Inspection key points: key links in the production, management, storage, use and transportation of liquefied gas such as liquid oxygen and explosive dangerous chemicals; The key link of insufficient safety protection distance and failure to implement safety measures in dangerous areas and residential areas.
Third, check the contents:
The person in charge of the unit shall organize the self-inspection and hidden danger investigation of the unit, and conduct a comprehensive and thorough inspection of the implementation of each link, each post and each safety measure.
Start self-inspection in full accordance with the industry safety standardization assessment methods, standardize and improve safety management, and improve the level of safety production; Improve various safety management systems, whether safety requirements and job responsibilities are put in place, and hidden dangers in process systems, infrastructure, technical equipment, filling environment and prevention and control measures. Specifically including:
1, implement the responsibility system for production safety. The legal person shall sign a letter of responsibility with the person in charge of safety, and the person in charge of safety shall sign a letter of responsibility with the safety officer to ensure that the responsibility is implemented to the specific person in charge.
2, production safety laws and regulations, standard procedures and system implementation. Implement safety measures in production and workplace according to the requirements of relevant laws, regulations and norms. All workplaces with Class A production, management, storage, transportation and fire hazards must be equipped with combustible gas alarms and other instruments and equipment, emergency rescue equipment and occupational health protection equipment, and emergency shower facilities. Equipment, pipelines, electrical equipment, etc. Flammable and explosive workplaces with Class A fire hazards must be explosion-proof.
3. Hidden dangers investigation and rectification and monitoring of major hazard sources. Important facilities, equipment and daily safety production management; Archives account, monitoring and emergency management of hidden dangers investigation and management; Inspection of cryogenic liquid storage tanks, gas cylinders and means of transport.
4. Emergency management. According to the requirements of "Guidelines for Preparing Emergency Rescue Plans for Hazardous Chemicals Accidents (Unit Edition)", combined with the actual production and use of hazardous chemicals, formulate and improve targeted and operable emergency plans for accidents, and organize employees to conduct drills at least once a year, and the drills must be recorded.
Fourth, the inspection results
The three low-temperature storage tanks, pressure pipes and pressure vessels of this unit all meet the national safety standards, the production process is safe and reasonable, and the environmental sanitation of the factory area meets the relevant national requirements.